Major Depressive Disorder
Conditions
Keywords
Depression, Geriatric, MRI, Sertraline
Brief summary
The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.
Interventions
DRUGSertraline
Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day. Duration of treatment was 12 weeks.
Sponsors
Pfizer
National Alliance for Research on Schizophrenia and Depression
Mclean Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* DSM- IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) diagnostic criteria for major depressive disorder * Hamilton Depression Scale- 17 item version score of 18 or higher * Must speak English * Women must be post-menopausal
Exclusion criteria
* A current or pervious psychiatric disorder other than MDD * A current unstable medical condition * A pacemaker or metal implant * History of alcohol or drug dependence or abuse within the past year * Current prescription of excluded medications * Use of a drug within the last 30 days that was not approved for use by governmental authorities. * If you or a family member works at McLean Hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAM-D 17 (Hamilton Depression Rating Scale) | baseline at study entry week 0 | This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness. Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms). |
| Geriatric Depression Scale | baseline at study entry week 0 | This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms). |
| Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | at week 0 for both control and depressed, and at week 12 for depressed | The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index. beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Controls (Baseline) Healthy Controls undergo MRI and neuropsychological testing | 17 |
| Depressed (Baseline) Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day. | 26 |
| Total | 43 |
Baseline characteristics
| Characteristic | Depressed (Baseline) | Healthy Controls (Baseline) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 1 Participants | 12 Participants |
| Age, Continuous | 69.3 years STANDARD_DEVIATION 10.7 | 72.6 years STANDARD_DEVIATION 4.8 | 70.6 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 26 participants | 17 participants | 43.0 participants |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 21 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 4 / 26 |
| serious Total, serious adverse events | 0 / 17 | 0 / 26 |
Outcome results
Primary
Geriatric Depression Scale
This is a depression severity rating scale measuring symptoms of depression. Scale is from 0 (no depression symptoms) up to a maximum of 15 (severe depression symptoms).
Time frame: baseline at study entry week 0
Population: Not all subjects included in MRS analysis had baseline GDS data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls (Baseline) | Geriatric Depression Scale | 0.6 Units on a scale | Standard Deviation 0.51 |
| Depressed (Baseline) | Geriatric Depression Scale | 9.1 Units on a scale | Standard Deviation 1.6 |
Primary
HAM-D 17 (Hamilton Depression Rating Scale)
This is a depression severity rating scale measuring symptoms of depression including mood, sleep, appetite, energy, motivation, guilt, suicidal ideation, concentration, physical complaints, paranoia, anxiety, effect on daily functioning and awareness of illness. Scale is from 0 (no depression symptoms) up to a maximum of 66 (severe depression symptoms).
Time frame: baseline at study entry week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Controls (Baseline) | HAM-D 17 (Hamilton Depression Rating Scale) | 1.0 Units on a scale | Standard Deviation 1.1 |
| Depressed (Baseline) | HAM-D 17 (Hamilton Depression Rating Scale) | 18.5 Units on a scale | Standard Deviation 6.5 |
Primary
Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)
The primary outcome is a phosphorus magnetic resonance spectroscopy (31P-MRS) signal quantified using a spectral time-domain fitting program based on the Marquadt-Levenberg non-linear, least-squares algorithm, that incorporates prior knowledge of spectral peak assignments, chemical shifts and J-coupling constants. Least squares means were calculated for average total signal using linear mixed effects models. Results are expressed as a spectroscopic index. beta-nucleoside triphosphate (bNTP) Phosphocreatine (PCr) Total nucleoside triphosphate (NTP)
Time frame: at week 0 for both control and depressed, and at week 12 for depressed
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Controls (Baseline) | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | PCr | .0496 Spectroscopic Index | Standard Error 0.0009 |
| Healthy Controls (Baseline) | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | bNTP | .0432 Spectroscopic Index | Standard Error 0.0007 |
| Healthy Controls (Baseline) | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | Total NTP | .1509 Spectroscopic Index | Standard Error 0.0028 |
| Depressed (Baseline) | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | PCr | .0512 Spectroscopic Index | Standard Error 0.0008 |
| Depressed (Baseline) | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | bNTP | .0397 Spectroscopic Index | Standard Error 0.0006 |
| Depressed (Baseline) | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | Total NTP | .1420 Spectroscopic Index | Standard Error 0.0029 |
| Post-treatment Depressed | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | bNTP | .0410 Spectroscopic Index | Standard Error 0.0007 |
| Post-treatment Depressed | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | Total NTP | .1396 Spectroscopic Index | Standard Error 0.0028 |
| Post-treatment Depressed | Phosphorus Magnetic Resonance Spectroscopy (31P-MRS) | PCr | .0515 Spectroscopic Index | Standard Error 0.0009 |